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Dabigatran etexilate is another new anticoagulant, an oral inhibitor of thrombin that could help prevent venous thromboembolism after major orthopaedic surgery. The manufacturers tested it in a head to head trial against subcutaneous enoxaparin. They found that after about a month of treatment, the two drugs worked equally well in patients having a hip replacement. Rates of deep vein thrombosis, pulmonary embolism, or death were similar in all three randomised groups—6.7% (60/897) for patients given enoxaparin, 6.0% (53/880) for those given a high dose of dabigatran, and 8.6% (75/874) for those given a lower dose.
No extra bleeding complications occurred in patients given the new agent in either dose. But there were too few events to be completely certain about this result. Bigger trials focusing on safety are now needed, say the authors.
The trial's biggest limitation was that nearly a quarter of the patients were excluded from the analysis, mostly because they didn't have a venogram or the image wasn't clear enough to interpret. This is a common problem for researchers using venography to look for venous thromboembolism, says an editorial (p 915). Its effects are unknown.